On December 19, 2006 the US Pandemic and All-Hazards Preparedness Act of 2006 was passed [1, 2] under which Biomedical Advanced Research and Development Authority (BARDA) [3] was established within the new Office of the Assistant Secretary for Preparedness and Response (ASPR) [6] in the U.S. Department of Health and Human Services (HHS). [4, 7]
BARDA was established under Title IV of the Act within HHS to “coordinate the acceleration of countermeasure and product advanced research and development”
“BARDA was created to fill a critical gap in the U.S. Government medical countermeasure development pipeline and procurement processes by providing financial and technical support for companies entering the late stages of product development, which have been called the “Valley of Death”. Using a variety of mechanisms, BARDA supports the transition of promising MCM candidates from early research through advanced development to approval and production and, where appropriate, into national stockpiles.” [5]
BARDA uses Project BioShield funding to work with private industry for the procurement and advanced development of medical countermeasures for chemical, biological, radiological, and nuclear agents (CBRN). [8]